Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune Mediated Inflammatory Diseases 1st Edition by Honghui Zhou, Diane Mould ISBN 111928919X 9781119289197

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Product details:
ISBN 10: 111928919X
ISBN 13: 9781119289197
Author: Honghui Zhou, Diane Mould

With increasing numbers of patients suffering from Immune-Mediated Inflammatory Diseases (IMIDs), and with the increasing reliance on biopharmaceuticals to treat them, it is imperative that researchers and medical practitioners have a thorough understanding of the absorption, distribution, metabolism and excretion (ADME) of therapeutic proteins as well as translational pharmacokinetic/pharmacodynamic (PK/PD) modeling for them. This comprehensive volume answers that need to be addressed.

Featuring eighteen chapters from world-renowned experts and opinion leaders in pharmacology, translational medicine and immunology, editors Honghui Zhou and Diane Mould have curated a much-needed collection of research on the advanced applications of pharmacometrics and systems pharmacology to the development of biotherapeutics and individualized treatment strategies for the treatment of IMIDs. Authors discuss the pathophysiology of autoimmune diseases in addition to both theoretical and practical aspects of quantitative pharmacology for therapeutic proteins, current translational medicine research methodologies and novel thinking in treatment paradigm strategies for IMIDs. Other notable features include:

•          Contributions from well-known authors representing leading academic research centers, specialized contract research organizations and pharmaceutical industries whose pipelines include therapeutic proteins

•          Chapters on a wide range of topics (e.g., pathophysiology of autoimmune diseases, biomarkers in ulcerative colitis, model-based meta-analysis use in the development of therapeutic proteins)

•          Case studies of applying quantitative pharmacology approaches to guiding therapeutic protein drug development in IMIDs such as psoriasis, inflammatory bowel disease, multiple sclerosis and lupus

Zhou and Mould’s timely contribution to the critical study of biopharmaceuticals is a valuable resource for any academic and industry researcher working in pharmacokinetics, pharmacology, biochemistry, or biotechnology as well as the many clinicians seeking the safest and most effective treatments for patients dealing with chronic immune disorders.

Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune Mediated Inflammatory Diseases 1st Edition Table of contents:

Part 1: Foundations of Quantitative Pharmacology

1. Introduction to Quantitative Pharmacology
2. Pharmacokinetics and Pharmacodynamics: Fundamental Principles
3. Systems Pharmacology and Disease Modeling

Part 2: Therapeutic Proteins and Their Role in Immune-Mediated Inflammatory Diseases
4. Overview of Immune-Mediated Inflammatory Diseases (IMIDs)
5. Therapeutic Proteins: Monoclonal Antibodies, Fusion Proteins, and Cytokine Inhibitors
6. Mechanisms of Action of Biologic Therapies

Part 3: Drug Development Strategies for Therapeutic Proteins
7. Preclinical Development of Therapeutic Proteins
8. Clinical Development Phases for Biologics
9. Biomarkers and Translational Pharmacology in IMID Therapy

Part 4: Quantitative Pharmacology in Individualized Therapy
10. Population Pharmacokinetics and Pharmacodynamics Modeling
11. Adaptive Dosing Strategies in Biologic Therapy
12. Therapeutic Drug Monitoring (TDM) for Therapeutic Proteins

Part 5: Advanced Modeling Approaches
13. Machine Learning and Artificial Intelligence in Drug Development
14. Physiologically Based Pharmacokinetic (PBPK) Models for Biologics
15. Bayesian Modeling for Personalized Therapeutics

Part 6: Case Studies and Applications
16. Case Study: Development of TNF-α Inhibitors
17. Case Study: IL-6 Pathway Inhibitors in Rheumatoid Arthritis
18. Real-World Applications of Individualized Therapy

Part 7: Challenges and Future Directions
19. Immunogenicity of Therapeutic Proteins: Challenges and Mitigation Strategies
20. Regulatory Considerations in the Development of Biologics
21. Emerging Trends in Biologic Therapies for IMIDs

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